Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000069550
Ethics application status
Approved
Date submitted
2/02/2006
Date registered
20/02/2006
Date last updated
11/02/2020
Date data sharing statement initially provided
11/02/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
REgulation of Coagulation in ORthopedic Surgery to prevent DVT and PE, controlled, double-blind, randomized study of BAY 59-7939 in the extended prevention of VTE in patients undergoing elective total hip replacement.
Scientific title
Regulation of Coagulation in Orthopedic Surgery to prevent Deep Venous Thrombosis and Pulmonary Embolism, controlled, double-blind, randomized study of BAY 59-7939 administered for 5 weeks compared with enoxaparin administered for 10 - 12 days in the extended prevention of Venous Thromboembolism in patients undergoing elective total hip replacement.
Secondary ID [1] 241 0
Bayer Australia Ltd: Bay 59-7939/11357
Universal Trial Number (UTN)
Trial acronym
RECORD 2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Patients undergoing total hip replacement. 1033 0
Condition category
Condition code
Cardiovascular 1108 1108 0 0
Other surgery
Musculoskeletal 1109 1109 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The patients will be randomized to I treatment group.

I. 10 mg od of Bay 59-7939 tablets active substance (10 mg tablet) from Day 1 to Day 35 plus a placebo syringe of enoxaparin from Day 0 - Day 12

Day 1 will be defined as the day of the elective total hip replacement. On Day 1 the first dose of BAY 59-7939 or matching placebo and the second dose of enoxaparin or matching placebo will be administered post-operatively 6-8 hours after wound closure. Active treatment period for the Enoxaparin arm is day 0 to day 12. The active treatment period for BAY 59-3979 arm is from Day 1 until day 35.

On day 36 a bilateral ascending venography is mandatory for all patients. If symptoms of DVT occur earlier, an ultrasound may be allowed. If the DVT is confirmed by ultrasound, a bilateral ascending venography is mandatory for all patients. No further study medication will be administered after the venography.
If symptoms of pulmonary embolism occur during the study (including follow-up of 30 days post study treatment) a lung scintigraphy with chest X-Ray or a spiral CT or a pulmonary angiography should be performed. Symptoms of DVT occurring during follow-up should be verified by ultrasound or venography.
Intervention code [1] 879 0
Prevention
Comparator / control treatment
The patients will be randomized to II treatment group. II. One placebo tablet of BAY 59-7939 from Day 1 to Day 35 plus one syringe of enoxaparin active substance at a dose of 40 mg from Day 0 to Day 12.
Control group
Active

Outcomes
Primary outcome [1] 1478 0
The primary efficacy endpoint as assessed by venography, is defined as a composite endpoint of:
- Any DVT (proximal and/or distal)
Timepoint [1] 1478 0
Assessed at day 36
Primary outcome [2] 1479 0
The primary efficacy endpoint as assessed by venography, is defined as a composite endpoint of:
- Non fatal PE
Timepoint [2] 1479 0
Assessed at day 36
Primary outcome [3] 1480 0
The primary efficacy endpoint as assessed by venography, is defined as a composite endpoint of:
- Death from all causes.
Timepoint [3] 1480 0
Assessed at day 36
Secondary outcome [1] 2656 0
Incidence of the composite endpoint comprising proximal DVT, non-fatal PE and VTE-related death.
Timepoint [1] 2656 0
Secondary efficacy endpoints as assessed at day 36 by venography.
Secondary outcome [2] 2657 0
Incidence of the composite endpoint that results from the primary endpoint by substituting VTE related death for all death (composite of any DVT and nonfatal PE and VTE-related death).
Timepoint [2] 2657 0
Secondary efficacy endpoints as assessed at day 36 by venography.
Secondary outcome [3] 2658 0
Incidence of the composite endpoint that results from major VTE by substituting all cause mortality for VTE related death (composite of proximal DVT and nonfatal PE and death from all causes ).
Timepoint [3] 2658 0
Secondary efficacy endpoints as assessed at day 36 by venography.
Secondary outcome [4] 2659 0
Incidence of symptomatic VTE (DVT, PE).
Timepoint [4] 2659 0
Secondary efficacy endpoints as assessed at day 36 by venography.
Secondary outcome [5] 2660 0
Incidence of DVT (total, proximal, distal).
Timepoint [5] 2660 0
Secondary efficacy endpoints as assessed at day 36 by venography.
Secondary outcome [6] 2661 0
Incidence of symptomatic VTE during follow-up.
Timepoint [6] 2661 0
Secondary efficacy endpoints as assessed at day 36 by venography.

Eligibility
Key inclusion criteria
Patients scheduled for elective total hip replacement.- Patients’ written informed consent for participation after receiving detailed written and oral information previous to any study specific procedures.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Planned, staged total bilateral hip replacement.- Active bleeding or high risk of bleeding contraindicating treatment with low molecular weight heparin.- Contraindication listed in the labeling or conditions precluding patient treatment with enoxaparin.- Conditions prohibiting bilateral venography (amputation of one leg, allergy to contrast media).- Pregnant and breast-feeding women. Women with child-bearing potential not using adequate birth control method. - Drug or alcohol abuse.- Concomitant use of HIV-protease inhibitors.- Therapy with another investigational product within 30 days prior start of study.- Planned intermittent pneumatic compression during active treatment period.- Concomitant participation in another trial or study.- Ongoing oral anticoagulant therapy that cannot be stopped in the opinion of the investigator.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The packaging and dosage will be such, that the different treatment groups will appear identical. An interactive voice response system (IVRS) will be used to accomplish a blind allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated random code
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/03/2006
Actual
19/02/2006
Date of last participant enrolment
Anticipated
Actual
27/02/2007
Date of last data collection
Anticipated
Actual
7/05/2007
Sample size
Target
2500
Accrual to date
Final
2451
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1213 0
Commercial sector/Industry
Name [1] 1213 0
Bayer Australia Limited
Country [1] 1213 0
Australia
Funding source category [2] 1214 0
Commercial sector/Industry
Name [2] 1214 0
Johnson and Johnson
Country [2] 1214 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Bayer Australia Limited
Address
875 Pacific Highway Pymble NSW 2073
Country
Australia
Secondary sponsor category [1] 1072 0
Commercial sector/Industry
Name [1] 1072 0
Johnson and Johnson
Address [1] 1072 0
Raritan NJ 08869
Country [1] 1072 0
United States of America

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305338 0
Prince of Wales Hospital Human Research Ethics Committee - Eastern Section
Ethics committee address [1] 305338 0
Ethics committee country [1] 305338 0
Australia
Date submitted for ethics approval [1] 305338 0
14/12/2005
Approval date [1] 305338 0
06/02/2006
Ethics approval number [1] 305338 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36119 0
Address 36119 0
Country 36119 0
Phone 36119 0
Fax 36119 0
Email 36119 0
Contact person for public queries
Name 10068 0
Clinical Research Manager
Address 10068 0
Bayer Australia Limited
PO Box 903
Pymble NSW 2073
Country 10068 0
Australia
Phone 10068 0
+61 2 93916140
Fax 10068 0
Email 10068 0
[email protected]
Contact person for scientific queries
Name 996 0
Medical Services Manager
Address 996 0
Bayer Australia Limited
PO Box 903
Pymble NSW 2073
Country 996 0
Australia
Phone 996 0
+61 2 93916147
Fax 996 0
Email 996 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.